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Revocation of Registration Certificate in the Republic of Kazakhstan

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Revocation of Registration Certificate in the Republic of Kazakhstan

Dear partners!

We want to share useful information about when it is possible to withdraw the Registration Certificate on the territory of the Republic of Kazakhstan and its possible implementation. Below are the General provisions in accordance with regulatory legal acts No. 193, No. 106

Normative legal acts:

The Code of the Republic of Kazakhstan dated September 18, 2009 No. 193-IV “On the Health of the People and the Health Care System”.

Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated February 27, 2015 No. 106 “On approval of the Rules for suspension, prohibition or withdrawal from circulation or restriction of the use of medicines and medical devices”.

Conditions for revoking a Registration Certificate from the market:

  • non-compliance of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;
  • identifying adverse reactions of drugs hazardous to human health that are not specified in the instructions for medical use of the drug, or increasing the frequency of detection of cases of serious adverse reactions specified in the instructions, or low therapeutic efficacy (lack of therapeutic effect), or the availability of information about the suspension and (or) recalling it from the market of other countries in connection with the identification of serious adverse reactions with an unfavorable benefit-risk ratio;
  • detection during the use of medical devices of design defects, the principle of operation, production performance, affecting the safety of their use;
  • violation of the approved process for the production of medicines and medical devices, affecting the safety, quality and effectiveness of their use;
  • the availability of data on harm to the health of the patient or consumer in connection with the use of medicines and medical devices;
  • obtaining data on the insufficiency of the scientific and technical level of production technology and quality control, ensuring a decrease in the safety level of the use of medicines and medical devices;
  • the application of the holder of the registration certificate for suspension, revocation of the registration certificate or withdrawal from circulation or restriction of the use of a medicinal product and medical device;
  • non-compliance of medicines with the requirements of good pharmaceutical practices of the Republic of Kazakhstan and (or) the Eurasian Economic Union identified by the results of the pharmaceutical inspection;
  • failure to fulfill pharmacovigilance obligations by the holder of the registration certificate of the medicinal product and the manufacturer of the medical device for monitoring the safety, quality and effectiveness of medical devices.

Person entitled to recall:

Authorized body, Manufacturer, Distributor (with the consent of the manufacturer)

Characters:

Authorized body, Manufacturer, Distributor (with the consent of the manufacturer)

List of documents required for revocation of the Registration Certificate

A letter of justification with a reason addressed to the Head of the National Electricity and Drug Administration (upon revocation of the Registration Certificate at the request of the manufacturer)

Timing

From the date of receipt of information from the manufacturer, that is, letters. The authorized body makes a decision on suspension within three calendar days. After making a decision, within one calendar day, the authorized body shall notify in writing (arbitrary) the territorial units of the authorized body, the owner of the Registration Certificate and the State Expert Organization.

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